Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma

Inclusion criteria

• . Patient must have histologically confirmed newly diagnosed glioblastoma (GBM, world health organization (WHO) grade IV). The histological diagnosis must have been made after biopsy or neurosurgical tumor resection.
• . The local O-6-Methylguanine-DNA Methyltransferase (MGMT) report determination should be available and should be uploaded to the electronic case report form (eCRF).
• . Patient should have had a gross total or subtotal resection performed \< 7 weeks prior to enrollment, documented at postoperative MRI. Patients who have had a biopsy only without resection are not eligible.
• . Patient deemed suitable by the treating physician to receive the standard radiotherapy regimen in combination with temozolomide.
• . Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 70 years of age.
• . Patient may have received and continue to receive corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to first dose of study treatment.
• . Patient has not received prior chemotherapy or radiotherapy.
• . Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥ 1.0 × 109/L; Platelet count ≥ 75,000/mm3 (75 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support

Exclusion criteria